ELITE PLUS 9651-28-040Recalls & reported problems
Depuy (Ireland) · ELITE PLUS Cup - CEMENTED LPW 28mmID 40mmOD · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295318521), received between Dec 14, 2017 and Jul 5, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Disassembly” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Disassembly1
- Naturally Worn1
Patient problems
- Joint Dislocation1
- No Code Available1
- No Consequences Or Impact To Patient1
- Not Applicable1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 5, 2018Disassembly; Disassembly
THE PRIMARY SURGERY WAS PERFORMED ON 2005 VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO REVISE THE CUP, THE HEAD, AND THE STEM DUE TO DISSOCIATION OF THE CUP AND THE HEAD. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.
Patient problems: Joint Dislocation; No Code Available; Not Applicable
MAUDE report 7663343 ↗InjuryDec 14, 2017Naturally Worn; Naturally Worn
THE PATIENT WAS REVISED TO ADDRESS WEAR OF THE CUP. DOI: 1999; DOR: (B)(6) 2017; UNKNOWN HIP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7117648 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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